Rouleaux Club - Jonathan Boyle MD, FRCS - Device Safety and Lessons Learned from the Nellix Experience

Apr 19, 2021

Rachael and Francesca discuss with Mr. Jonathan Boyle and Aminder vascular surgery registries in the UK, how they contribute to device safety and lessons learned from the Nellix experience.

Mr. Jonathan Boyle MD FRCS graduated from the University of Leicester in 1991, completed a Doctor of Medicine postgraduate research degree in 2000, and was appointed as a consultant vascular surgeon in Cambridge University Hospitals NHS Trust in 2002, where he was Clinical Lead for Vascular Surgery from 2014-17.

He has held numerous national and international leadership roles.  Amongst others, he is Vice President of the Vascular Society of Great Britain and Ireland (VSGBI), Past President of the British Society for Endovascular Therapy, and Section Editor of the European Journal of Vascular and Endovascular Surgery.

During his roles as Clinical Lead for the UK’s National Vascular Registry (NVR) and Chair of the VSGBI Audit and Quality Improvement Committee, he led the development of the Peripheral Artery Disease Quality Improvement Framework and, more recently, has introduced the incorporation of device-specific information into the NVR.  Under his leadership, the NVR team won the HQIP Team of the Year 2020 award in recognition of their “outstanding work on registry device capture, quality improvement and a rapid response to COVID-19”.  He has also worked closely with Medicines and Healthcare products Regulatory Agency on failing vascular devices.

Aminder Singh MBBS is an Academic Clinical Fellow at the University of Cambridge and vascular surgery specialty trainee in the East of England, currently undertaking research investigating the development of stem cell models to characterize aortopathy variants.  He is the venous and European rep on the Rouleaux Club Executive Committee.

Co-host: Francesca Guest MBChB is a vascular surgery specialty trainee on the South West England training program, currently working in Exeter.  She is the Association for Surgeons in Training (ASiT) rep on the Rouleaux Club Executive Committee.

Resources:

• UK Vascular Services Quality Improvement Programme (including the National Vascular Registry): https://www.vsqip.org.uk
• Vascular Society of Great Britain and Ireland: https://www.vascularsociety.org.uk
• UK National Joint Registry: https://www.njrcentre.org.uk/njrcentre/
• British Society for Endovascular Therapy: https://www.bset.co.uk

Relevant papers:

• Singh AA, Benaragama KS, Pope T, Coughlin PA, Winterbottom AP, Harrison SC, Boyle JR. Progressive Device Failure at Long Term Follow Up of the Nellix EndoVascular Aneurysm Sealing (EVAS) System. Eur J Vasc Endovasc Surg. 2021 Feb;61(2):211-218. doi: 10.1016/j.ejvs.2020.11.004. Epub 2020 Dec 7
• Singh AA, Boyle JR. Introduction of New Medical Devices: Lessons Learned From Experience With Endovascular Aneurysm Sealing. J Endovasc Ther. 2020 Feb;27(1):160-162.
• Singh AA, Boyle JR. Readmission and Re-intervention are Better Measures of EVAR Quality. Eur J Vasc Endovasc Surg. 2020 Oct;60(4):518. doi: 10.1016/j.ejvs.2020.08.011

Erratum: In the original publication, Mr. Singh stated that the Nellix device had been approved by the FDA.  This is incorrect and this device is still considered investigational in the USA.  The audio has been updated to reflect this correction.